FDA.reportPublic FDA data

NDC 51672-1300-09 - Ammonium Lactate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-1300
Requested NDC
51672-1300-09
Package NDCs from labels
51672-1300-5, 51672-1300-9, 51672-1300-09
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2026-07-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ammonium Lactate Lotion 12%*Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2026-07-30HUMAN PRESCRIPTION DRUG LABEL
Ammonium Lactate - A-S Medication SolutionsA-S Medication Solutions2023-08-24HUMAN PRESCRIPTION DRUG LABEL
Ammonium Lactate Lotion, 12%*V2 Pharma, LLC | Taro Pharmaceuticals Inc. | G&W Laboratories, Inc.2019-06-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
51672-1300-52023-02-08Ammonium Lactate Lotion 12%*
51672-1300-52023-02-08Ammonium Lactate Lotion 12%*
51672-1300-92023-02-08Ammonium Lactate Lotion 12%*
51672-1300-92023-02-08Ammonium Lactate Lotion 12%*
51672-1300-52023-01-30Ammonium Lactate Lotion 12%*
51672-1300-52023-01-30Ammonium Lactate Lotion 12%*
51672-1300-92023-01-30Ammonium Lactate Lotion 12%*
51672-1300-92023-01-30Ammonium Lactate Lotion 12%*

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1300-5Ammonium Lactate225 g in 1 BOTTLE, PLASTICLOTION2256
51672-1300-9Ammonium Lactate400 g in 1 BOTTLE, PLASTICLOTION4006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1300AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 2 package rows20240113_8bb09bb3-5bbc-489d-96c1-ae97cb58381e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1300-5GM - Gram51672-1300f3e5b834-7369-4e84-9ce1-821a26e0aa2512012-07-24
51672-1300-9GM - Gram51672-1300e7b6d29c-e373-44ab-a3cb-3ad3b3cee0d712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ammonium LactateACTIVE INGREDIENT67M901L9NQAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
lactic acidACTIVE MOIETY33X04XA5ATAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
laureth-4INACTIVE INGREDIENT6HQ855798JAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
light mineral oilINACTIVE INGREDIENTN6K5787QVPAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
peg-100 stearateINACTIVE INGREDIENTYD01N1999RAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 168 · 3,360 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Black Tea and BlackberryLIP BALM SUNSCREENJack Black, LLC172a70bc-8a09-4258-b9bf-cf3c67ff76132026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Cucumber LimeSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC5f15bee9-9bf4-4f27-a6b5-4205deb625f62026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm Vanilla BourbonAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC517040d1-e6ed-40ca-a46f-2f75403dbc3c2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Mango and MandarinSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8c55d1cd-cdd6-468b-8a17-b940c62101162026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intensive Therapy Lip Balm Mango Chili LimeAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC51349d57-b14d-4798-8d68-03fbe3713d1e2026-09-08WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.